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Yan JW, Nie M, Zhang H, Liu YM, Tang FS. Strengths, weaknesses, opportunities, and threats analysis of combination therapy for inflammatory bowel disease. World J Gastroenterol 2025; 31:100607. [PMID: 40061596 PMCID: PMC11886040 DOI: 10.3748/wjg.v31.i9.100607] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/21/2024] [Revised: 01/12/2025] [Accepted: 01/18/2025] [Indexed: 02/18/2025] Open
Abstract
Inflammatory bowel disease (IBD), encompassing Crohn's disease and ulcerative colitis, manifests as a chronic, recurrent, and refractory intestinal inflammatory condition significantly impacting patients' quality of life. Despite ongoing research, its etiology and pathogenesis remain incompletely understood. Recent advancements in medical research highlight the critical role of drug combination therapies in managing IBD. This paper employs the strengths, weaknesses, opportunities, and threats framework to evaluate the four strategic elements (strengths, weaknesses, opportunities, and threats) pertaining to combination therapies for IBD. Among the strengths, the paper underscores the efficacy of multi-targeted strategies, the advancement of personalized medicine, and the mitigation of drug resistance. Nonetheless, the analysis identifies significant weaknesses, including the prohibitive cost of treatment, issues with patient compliance, and the necessity for comprehensive long-term safety data. The paper also delineates opportunities to augment therapeutic success through the incorporation of biomarkers, the application of artificial intelligence, and extensive international collaborative efforts. In contrast, the paper does not shy away from addressing the threats, which include the potential for therapeutic resistance and the logistical challenges inherent in global therapy deployment. These initiatives aim to refine future therapeutic practices, fostering safer, more effective, and personalized treatment paradigms for IBD patients.
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Affiliation(s)
- Jia-Wang Yan
- Department of Clinical Pharmacy, Zunyi Medical University, Zunyi 563006, Guizhou Province, China
- Key Laboratory of Basic Pharmacology of Ministry of Education and Joint International Research Laboratory of Ethnomedicine of Ministry of Education, Zunyi Medical University, Zunyi 563006, Guizhou Province, China
- Key Laboratory of Basic Pharmacology of Guizhou Province and School of Pharmacy, Zunyi Medical University, Zunyi 563006, Guizhou Province, China
| | - Mei Nie
- Department of Clinical Pharmacy, Zunyi Medical University, Zunyi 563006, Guizhou Province, China
- Key Laboratory of Basic Pharmacology of Ministry of Education and Joint International Research Laboratory of Ethnomedicine of Ministry of Education, Zunyi Medical University, Zunyi 563006, Guizhou Province, China
- Key Laboratory of Basic Pharmacology of Guizhou Province and School of Pharmacy, Zunyi Medical University, Zunyi 563006, Guizhou Province, China
| | - Hang Zhang
- Department of Clinical Pharmacy, Zunyi Medical University, Zunyi 563006, Guizhou Province, China
- Key Laboratory of Basic Pharmacology of Ministry of Education and Joint International Research Laboratory of Ethnomedicine of Ministry of Education, Zunyi Medical University, Zunyi 563006, Guizhou Province, China
- Key Laboratory of Basic Pharmacology of Guizhou Province and School of Pharmacy, Zunyi Medical University, Zunyi 563006, Guizhou Province, China
| | - Yan-Miao Liu
- Key Laboratory of Basic Pharmacology of Ministry of Education and Joint International Research Laboratory of Ethnomedicine of Ministry of Education, Zunyi Medical University, Zunyi 563006, Guizhou Province, China
- Key Laboratory of Basic Pharmacology of Guizhou Province and School of Pharmacy, Zunyi Medical University, Zunyi 563006, Guizhou Province, China
- The First Clinical Institute, Zunyi Medical University, Zunyi 563006, Guizhou Province, China
| | - Fu-Shan Tang
- Department of Clinical Pharmacy, Zunyi Medical University, Zunyi 563006, Guizhou Province, China
- Key Laboratory of Basic Pharmacology of Ministry of Education and Joint International Research Laboratory of Ethnomedicine of Ministry of Education, Zunyi Medical University, Zunyi 563006, Guizhou Province, China
- Key Laboratory of Basic Pharmacology of Guizhou Province and School of Pharmacy, Zunyi Medical University, Zunyi 563006, Guizhou Province, China
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Xie WT, Yang H, Bai L, Wu FF. New perspectives and prospects for the next generation of combination therapy in inflammatory bowel disease. World J Gastroenterol 2025; 31:99462. [PMID: 39926226 PMCID: PMC11718608 DOI: 10.3748/wjg.v31.i5.99462] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/23/2024] [Revised: 11/23/2024] [Accepted: 12/10/2024] [Indexed: 12/30/2024] Open
Abstract
This article comments on the letter by Lowell et al, which addresses the next generation of combination therapy for inflammatory bowel disease (IBD). As the understanding of the pathogenesis of IBD continues to improve, treatment strategies are evolving rapidly. The letter examines the current status and future directions of combination therapy for IBD, focusing on approaches that combine biologics with immunomodulators and the emerging dual-biologic therapy (DBT). The traditional combination of biologics and immunomodulators has demonstrated preliminary efficacy by enhancing the effects of biologics through immunomodulation. However, concerns regarding long-term safety warrant careful evaluation. Recent trials, including DUET-Crohn's disease and DUET-ulcerative colitis, have shown promising potential for the broader adoption of DBT. Nevertheless, comprehensive data on efficacy and safety, as well as the effective integration of supportive treatments, remain essential to establish new paradigms for the next generation of IBD care.
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Affiliation(s)
- Wen-Ting Xie
- Guangdong Provincial Key Laboratory of Gastroenterology, Institute of Gastroenterology of Guangdong Province, Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou 510515, Guangdong Province, China
| | - Hui Yang
- Guangdong Provincial Key Laboratory of Gastroenterology, Institute of Gastroenterology of Guangdong Province, Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou 510515, Guangdong Province, China
| | - Lan Bai
- Guangdong Provincial Key Laboratory of Gastroenterology, Institute of Gastroenterology of Guangdong Province, Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou 510515, Guangdong Province, China
| | - Feng-Fei Wu
- Guangdong Provincial Key Laboratory of Gastroenterology, Institute of Gastroenterology of Guangdong Province, Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou 510515, Guangdong Province, China
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Lowell JA, Farber MJ, Sultan K. Back to the drawing board: Overview of the next generation of combination therapy for inflammatory bowel disease. World J Gastroenterol 2024; 30:3182-3184. [PMID: 39006384 PMCID: PMC11238668 DOI: 10.3748/wjg.v30.i25.3182] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/01/2024] [Revised: 05/27/2024] [Accepted: 06/12/2024] [Indexed: 07/01/2024] Open
Abstract
Inflammatory bowel disease (IBD) is entering a potentially new era of combined therapeutics. Triantafillidis et al provide an insightful review of the current state of combination therapy, with a focus on the use of a combined biologic and immunomodulator, as well as emerging data on the future potential of dual-biologic therapy (DBT). While current evidence for DBT is limited, encouraging safety profiles and ongoing trials suggest a brighter future for this approach. The importance of controlled trials should be stressed in establishing new treatment paradigms. Ongoing prospective randomized trials of DBT and perhaps future combinations of biologics and small molecule therapies will hopefully guide the next generation of IBD care.
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Affiliation(s)
- Jeffrey A Lowell
- Department of Medicine, Zucker School of Medicine at Hofstra, North Shore University Hospital-Long Island Jewish Medical Center, Manhasset, NY 11030, United States
| | - Michael J Farber
- Preclinical Studies, New York Institute of Technology College of Osteopathic Medicine, Glen Head, NY 11545, United States
| | - Keith Sultan
- Division of Gastroenterology, Northwell Health, North Shore University Hospital and Long Island Jewish Medical Center, Great Neck, NY 10021, United States
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Wei J, Zhang Y, Chen C, Feng X, Yang Z, Feng J, Jiang Q, Fu J, Xuan J, Gao H, Liao L, Wang F. Efficacy and safety of allogeneic umbilical cord-derived mesenchymal stem cells for the treatment of complex perianal fistula in Crohn's disease: a pilot study. Stem Cell Res Ther 2023; 14:311. [PMID: 37904247 PMCID: PMC10617053 DOI: 10.1186/s13287-023-03531-0] [Citation(s) in RCA: 9] [Impact Index Per Article: 4.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/15/2022] [Accepted: 10/10/2023] [Indexed: 11/01/2023] Open
Abstract
OBJECTIVES The aim of the study was to evaluate the efficacy and safety of allogeneic umbilical cord-derived mesenchymal stem cells (TH-SC01) for complex perianal fistula in patients with Crohn's disease (CD). METHODS This was an open-label, single-arm clinical trial conducted at Jinling Hospital. Adult patients with complex treatment-refractory CD perianal fistulas (pfCD) were enrolled and received a single intralesional injection of 120 million TH-SC01 cells. Combined remission was defined as an absence of suppuration through an external orifice, complete re-epithelization, and absence of collections larger than 2 cm measured by magnetic resonance imaging (MRI) at 24 weeks after cell administration. RESULTS A total of 10 patients were enrolled. Six patients (60.0%) achieved combined remission at 24 weeks. The number of draining fistulas decreased in 9 (90.0%) and 7 (70.0%) patients at weeks 12 and 24, respectively. Significant improvement in Perianal Crohn Disease Activity Index, Pelvic MRI-Based Score, Crohn Disease Activity Index, and quality of life score were observed at 24 weeks. No serious adverse events occurred. The probability of remaining recurrence-free was 70% at week 52. CONCLUSION The study demonstrated that local injection of TH-SC01 cells might be an effective and safe treatment for complex treatment-refractory pfCD after conventional and/or biological treatments fail (ClinicalTrials.gov ID, NCT04939337). TRIAL REGISTRATION The study was retrospectively registered on www. CLINICALTRIALS gov (NCT04939337) on June 25, 2021.
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Affiliation(s)
- Juan Wei
- Department of Gastroenterology and Hepatology, Jinling Hospital, Affiliated Hospital of Medical School of Nanjing University, No. 305 East Zhongshan Road, Nanjing, People's Republic of China
| | - Yufei Zhang
- Department of General Surgery, Jinling Hospital, Affiliated Hospital of Medical School of Nanjing University, No. 305 East Zhongshan Road, Nanjing, People's Republic of China
| | - Chunyan Chen
- Department of Gastroenterology and Hepatology, The First School of Clinical Medicine, Southern Medical University, Guangzhou Da Dao Bei 1838, Guangzhou, China
| | - Xiaoyue Feng
- Department of Gastroenterology and Hepatology, Jinling Hospital, Affiliated Hospital of Medical School of Nanjing University, No. 305 East Zhongshan Road, Nanjing, People's Republic of China
| | - Zhao Yang
- Department of Gastroenterology and Hepatology, Jinling Hospital, Affiliated Hospital of Medical School of Nanjing University, No. 305 East Zhongshan Road, Nanjing, People's Republic of China
| | - Jing Feng
- Department of Gastroenterology and Hepatology, The First School of Clinical Medicine, Southern Medical University, Guangzhou Da Dao Bei 1838, Guangzhou, China
| | - Qiong Jiang
- Department of Gastroenterology and Hepatology, Jinling Hospital, Affiliated Hospital of Medical School of Nanjing University, No. 305 East Zhongshan Road, Nanjing, People's Republic of China
| | - Jinjin Fu
- Department of Gastroenterology and Hepatology, The Affiliated Changzhou No. 2 People's Hospital, Nanjing Medical University, Changzhou, China
| | - Ji Xuan
- Department of Gastroenterology and Hepatology, Jinling Hospital, Affiliated Hospital of Medical School of Nanjing University, No. 305 East Zhongshan Road, Nanjing, People's Republic of China
| | - Hong Gao
- Department of Radiology, Jinling Hospital, Affiliated Hospital of Medical School of Nanjing University, No. 305 East Zhongshan Road, Nanjing, People's Republic of China
| | - Lianming Liao
- Center of Laboratory Medicine, Union Hospital of Fujian Medical University, No. 29, Xinquan Road, Fuzhou, 350001, People's Republic of China.
| | - Fangyu Wang
- Department of Gastroenterology and Hepatology, Jinling Hospital, Affiliated Hospital of Medical School of Nanjing University, No. 305 East Zhongshan Road, Nanjing, People's Republic of China.
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Shelygin YA, Ivashkin VT, Achkasov SI, Reshetov IV, Maev IV, Belousova EA, Vardanyan AV, Nanaeva BA, Adamyan LV, Drapkina OM, Namazova-Baranova LS, Razumovsky AY, Revishvili AS, Khatkov IE, Shabunin AV, Livzan MA, Sazhin AV, Timerbulatov VM, Khlynova OV, Abdulganieva DI, Abdulkhakov RA, Aleksandrov TL, Alekseeva OP, Alekseenko SA, Anosov IS, Bakulin IG, Barysheva OY, Bolikhov KV, Veselov VV, Golovenko OV, Gubonina IV, Dolgushina AI, Zhigalova TN, Kagramanova AV, Kashnikov VN, Knyazev OV, Kostenko NV, Likutov AA, Lomakina EY, Loranskaya ID, Mingazov AF, Moskalev AI, Nazarov IV, Nikitina NV, Odintsova AH, Omelyanovsky VV, Osipenko MF, Оshchepkov АV, Pavlenko VV, Poluektova EA, Rodoman GV, Segal AM, Sitkin SI, Skalinskaya MI, Surkov AN, Sushkov OI, Tarasova LV, Uspenskaya YB, Frolov SA, Chashkova EY, Shifrin OS, Shcherbakova OV, Shchukina OB, Shkurko TV, Makarchuk PA. Clinical guidelines. Crohn’s disease (К50), adults. KOLOPROKTOLOGIA 2023; 22:10-49. [DOI: 10.33878/2073-7556-2023-22-3-10-49] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 09/17/2024]
Affiliation(s)
- Yury A. Shelygin
- Ryzhikh National Medical Research Center of Coloproctology; Russian Medical Academy of Continuous Professional Education
| | | | - Sergey I. Achkasov
- Ryzhikh National Medical Research Center of Coloproctology; Russian Medical Academy of Continuous Professional Education
| | - Igor V. Reshetov
- I.M. Sechenov First Moscow State Medical University (Sechenov University)
| | - Igor V. Maev
- Moscow State University of Medicine and Dentistry named after A.I. Evdokimov
| | | | | | | | - Leila V. Adamyan
- Moscow State University of Medicine and Dentistry named after A.I. Evdokimov; Mational Medical Research Center of Obstetrics and Gynecology named after V.I. Kulakov
| | - Oksana M. Drapkina
- Moscow State University of Medicine and Dentistry named after A.I. Evdokimov; National Medical Research Center for Therapy and Preventive Medicine
| | - Leila S. Namazova-Baranova
- Reseach Instinute of Pediatrics and Child Health Protection of the Central Clinical Hospital of the Russian Academy of Sciences
| | | | - Amiran Sh. Revishvili
- A.V. Vishnevsky National Medical Research Center of Surgery; Russian Medical Academy of Continuous Professional Education
| | - Igor E. Khatkov
- Moscow Clinical/research Center named after A.S. Loginov" of the Moscow Department of Health
| | | | | | | | | | - Olga V. Khlynova
- Perm State Medical University named after Academician E.A. Wagner" of the Ministry of Health of Russia
| | | | | | | | - Olga P. Alekseeva
- Nizhny Novgorod Regional Clinical Hospital named after N.A. Semashko
| | | | - Ivan S. Anosov
- Ryzhikh National Medical Research Center of Coloproctology
| | - Igor G. Bakulin
- I.I. Mechnikov Northwestern State Medical University of the Ministry of Health of Russia
| | - Olga Yu. Barysheva
- Petrozavodsk State University of the Ministry of Education and Science of Russia
| | | | - Viktor V. Veselov
- Ryzhikh National Medical Research Center of Coloproctology; Russian Medical Academy of Continuous Professional Education
| | | | | | | | | | - Anna V. Kagramanova
- Moscow Clinical/research Center named after A.S. Loginov" of the Moscow Department of Health
| | | | - Oleg V. Knyazev
- Moscow Clinical/research Center named after A.S. Loginov" of the Moscow Department of Health
| | | | | | | | | | | | | | | | | | - Alfia H. Odintsova
- Clinical Hospital of the Ministry of Health of the Republic of Tatarstan
| | | | | | | | | | | | | | | | - Stanislav I. Sitkin
- I.I. Mechnikov Northwestern State Medical University of the Ministry of Health of Russia
| | - Maria I. Skalinskaya
- I.I. Mechnikov Northwestern State Medical University of the Ministry of Health of Russia
| | - Andrey N. Surkov
- Reseach Instinute of Pediatrics and Child Health Protection of the Central Clinical Hospital of the Russian Academy of Sciences
| | | | | | | | | | | | - Oleg S. Shifrin
- I.M. Sechenov First Moscow State Medical University (Sechenov University)
| | | | - Oksana B. Shchukina
- First St. Petersburg State Medical University named after Academician I.P. Pavlov
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Miklusiak K, Miklusiak K, Kaczmarczyk O, Cibor D, Zwolińska-Wcisło M. Ustekinumab in the treatment of acute disseminated pyoderma gangrenosum in a patient with Crohn's disease. Dermatol Reports 2023; 15:9630. [PMID: 37908604 PMCID: PMC10614552 DOI: 10.4081/dr.2023.9630] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/14/2022] [Accepted: 12/03/2023] [Indexed: 11/02/2023] Open
Abstract
Pyoderma gangrenosum (PG) is an auto-inflammatory dermatosis characterized by lesions that often cause ulcers. We present a case of successful ustekinumab treatment for acute general PG in a 31-year-old woman with coexisting Crohn's disease (CD). For a month, the patient suffered from skin ulcers, two of them deep and necrotic; a histopathological examination revealed PG. Treatment included: methylprednisolone, azathioprine, betamethasone, gentamicin and zincic ointments, antiseptic compresses, and adalimumab therapy. Due to resistance to the implemented treatment, the patient was enrolled in a clinical trial that included the administration of an anti-cytokines drug, ustekinumab. Subsequently, a significant reduction was observed in the severity of symptoms of PG with no relapse. The use of ustekinumab in patients with PG who have an inadequate response to current treatment or cannot receive first-line treatment can be considered. This applies especially to patients with accompanying autoimmune diseases such as CD.
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Affiliation(s)
| | - Karol Miklusiak
- Polish Red Cross Maritime Hospital with Oncology Centre, Gdynia
| | - Olga Kaczmarczyk
- Department of Gastroenterology and Hepatology, Jagiellonian University Medical College, Cracow, Poland
| | - Dorota Cibor
- Department of Gastroenterology and Hepatology, Jagiellonian University Medical College, Cracow, Poland
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Kamp K, Clark-Snustad K, Yoo L, Winders S, Cain K, Levy RL, Dey N, Lee S, Keefer L, Heitkemper M. A Comprehensive Self-Management Intervention for Inflammatory Bowel Disease (CSM-IBD): Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc 2023; 12:e46307. [PMID: 37285195 DOI: 10.2196/46307] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/17/2023] [Revised: 04/27/2023] [Accepted: 04/30/2023] [Indexed: 06/08/2023] Open
Abstract
BACKGROUND Despite pharmacological treatment, individuals with inflammatory bowel disease (IBD) experience a variety of symptoms, including abdominal pain, fatigue, anxiety, and depression. Few nonmedical self-management interventions are available for people with IBD. A validated comprehensive self-management (CSM) intervention is effective for patients with irritable bowel syndrome who can have symptoms similar to those of individuals with IBD. We created a modified CSM intervention tailored to individuals with IBD (CSM-IBD). The CSM-IBD is an 8-session program delivered over 8-12 weeks with check-ins with a registered nurse. OBJECTIVE The primary objective of this pilot study is to determine the feasibility and acceptability of study procedures and the CSM-IBD intervention and to evaluate preliminary efficacy on quality of life and daily symptoms for a future randomized controlled trial. Additionally, we will examine the association of socioecological, clinical, and biological factors with symptoms at baseline and response to intervention. METHODS We are conducting a pilot randomized controlled trial of the CSM-IBD intervention. Participants aged 18-75 years who are experiencing at least 2 symptoms are eligible for inclusion. We plan to enroll 54 participants who will be randomized (2:1) into the CSM-IBD program or usual care. Patients in the CSM-IBD program will have 8 intervention sessions. Primary study outcomes include the feasibility of recruitment, randomization, and data or sample collection, as well as the acceptability of study procedures and interventions. Preliminary efficacy outcome variables include quality of life and symptoms. Outcomes data will be assessed at baseline, immediately post intervention, and 3 months post intervention. Participants in the usual care group will have access to the intervention after study participation. RESULTS This project is funded by the National Institutes of Nursing Research and reviewed by the University of Washington's institutional review board. Recruitment began in February 2023. As of April 2023, we have enrolled 4 participants. We expect the study to be completed by March 2025. CONCLUSIONS This pilot study will evaluate the feasibility and efficacy of a self-management intervention (a web-based program with weekly check-ins with a registered nurse) that aims to improve symptom management in individuals with IBD. In the long term, we aim to validate a self-management intervention to improve patient quality of life, reduce direct and indirect costs related to IBD, and be culturally appropriate and accessible, particularly in rural and underserved communities. TRIAL REGISTRATION ClinicalTrials.gov NCT05651542; https://clinicaltrials.gov/ct2/show/NCT05651542. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) PRR1-10.2196/46307.
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Affiliation(s)
- Kendra Kamp
- Department of Biobehavioral Nursing and Health Informatics, School of Nursing, University of Washington, Seattle, WA, United States
| | - Kindra Clark-Snustad
- Division of Gastroenterology, School of Medicine, University of Washington, Seattle, WA, United States
| | - Linda Yoo
- Department of Biobehavioral Nursing and Health Informatics, School of Nursing, University of Washington, Seattle, WA, United States
| | - Samantha Winders
- Department of Biobehavioral Nursing and Health Informatics, School of Nursing, University of Washington, Seattle, WA, United States
| | - Kevin Cain
- Department of Biobehavioral Nursing and Health Informatics, School of Nursing, University of Washington, Seattle, WA, United States
| | - Rona L Levy
- School of Social Work, University of Washington, Seattle, WA, United States
| | - Neelendu Dey
- Fred Hutchinson Cancer Center, Seattle, WA, United States
| | - Scott Lee
- Division of Gastroenterology, School of Medicine, University of Washington, Seattle, WA, United States
| | | | - Margaret Heitkemper
- Department of Biobehavioral Nursing and Health Informatics, School of Nursing, University of Washington, Seattle, WA, United States
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Spencer EA, Abbasi S, Kayal M. Barriers to optimizing inflammatory bowel disease care in the United States. Therap Adv Gastroenterol 2023; 16:17562848231169652. [PMID: 37163167 PMCID: PMC10164253 DOI: 10.1177/17562848231169652] [Citation(s) in RCA: 7] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/21/2022] [Accepted: 03/17/2023] [Indexed: 05/11/2023] Open
Abstract
Significant progress in the management and modification of inflammatory bowel disease (IBD) has been made; however, significant barriers to the optimization of IBD care in the United States still exist. The majority of these barriers are constructed by insurance carriers and the integration of market pressures into healthcare decision-making. In this review, we highlight the barriers to IBD care optimization within the context of the US insurance system and review current and proposed solutions.
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Affiliation(s)
- Elizabeth A. Spencer
- Division of Pediatric Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA
| | - Sadeea Abbasi
- Division of Gastroenterology, Cedars-Sinai Santa Monica Gastroenterology, Santa Monica, CA, USA
| | - Maia Kayal
- The Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place Box 1069, New York, NY 10029, USA
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9
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Ustekinumab Promotes Radiological Fistula Healing in Perianal Fistulizing Crohn's Disease: A Retrospective Real-World Analysis. J Clin Med 2023; 12:jcm12030939. [PMID: 36769587 PMCID: PMC9917613 DOI: 10.3390/jcm12030939] [Citation(s) in RCA: 9] [Impact Index Per Article: 4.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/31/2022] [Revised: 01/17/2023] [Accepted: 01/22/2023] [Indexed: 01/27/2023] Open
Abstract
There is insufficient evidence to confirm the efficacy of ustekinumab (UST) in promoting fistula closure in perianal fistulizing Crohn's disease (CD) patients. We aimed to evaluate the efficacy of UST in a real-world setting. The data were retrospectively analyzed. Intestinal clinical and endoscopic changes were evaluated. Fistula radiological outcomes were determined using the Van Assche score. A total of 108 patients were included, 43.5% of whom had complex perianal fistulas. Intestinal clinical and endoscopic remission was achieved in 65.7% and 31.5% of patients, respectively. The fistula clinical remission and response rates were 40.7% and 63.0%, respectively, with a significant reduction in Perianal Crohn's disease Activity Index [5.0(3.0, 8.0) vs. 7.5(5.0, 10.0), p < 0.001] and Crohn's Anal Fistula Quality of Life [23.5(9.3, 38.8) vs. 49.0(32.3, 60.0), p < 0.001]. Radiological healing, partial response, no change, and deterioration were observed in 44.8%, 31.4%, 13.4%, and 10.4% of patients, respectively. The cut-off UST trough concentration for predicting fistula clinical remission was 2.11 μg/mL with an area under the curve of 0.795, a sensitivity of 93.3%, and a specificity of 67.6%. UST is efficacious in promoting radiological fistula closure in patients with perianal fistulizing CD. A UST trough concentration over 2.11 μg/mL was correlated with a higher likelihood of perianal fistula clinical remission.
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10
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Abdullah I, Alhendi G, Alhadab A, Alasfour H, Shehab M. Gastroenterologists Adherence to Tumor Necrosis Factor Antagonist Combination Therapy in Inflammatory Bowel Disease. Front Med (Lausanne) 2021; 8:725512. [PMID: 34660635 PMCID: PMC8511459 DOI: 10.3389/fmed.2021.725512] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/15/2021] [Accepted: 08/30/2021] [Indexed: 11/13/2022] Open
Abstract
Introduction: Tumor necrosis factor antagonists (anti-TNF) therapies are used for the management of moderate to severe inflammatory bowel disease (IBD). Anti-TNF combination therapy, with immunomodulators, has been shown to reduce immunogenicity, especially for infliximab, improve treatment success rate and patient outcomes. We evaluated factors associated with gastroenterologists adherence to anti-TNF combination therapy. Methods: A retrospective cohort study was performed to evaluate the adherence of gastroenterologists (n = 14), at an inflammatory bowel disease center, to anti-TNF combination therapy. Records of patients who received Infliximab (n = 137) or adalimumab (n = 152) were obtained and their ordering physicians' data was analyzed. Gastroenterologists were divided into six groups according to their age and interest in IBD. The baseline characteristics of their patients were also obtained. Results: The proportion of patients on combination therapy in the young gastroenterologists group was higher than those in the senior gastroenterologists group for both infliximab (83.2 vs. 55.6%, respectively, P < 0.001) and adalimumab (59 vs. 30.8%, respectively, P < 0.001). Gastroenterologists with interest in inflammatory bowel disease (IBD interest group) had also more proportion of patients on adalimumab combination therapy compared to gastroenterologists with no interest in IBD (non-IBD interest group) (61.7 vs. 35.2%, respectively, P < 0.001). Gastroenterologists who were both young and have interest in IBD had more proportion of patients on combination therapy than those who were senior or had no interest in IBD for both infliximab (89.4 vs. 63.4%, respectively, P < 0.001) and adalimumab (75.9 vs. 33%, P < 0.001). The IBD interest group was also requesting more antidrug antibody level tests than those in the non-IBD interest group (41.4 vs. 12.3 tests, respectively, P < 0.001). Conclusion: Young gastroenterologists are more likely to prescribe anti-TNF infliximab and adalimumab combination therapy than senior gastroenterologists. In addition, gastroenterologists with IBD interest are more likely to prescribe adalimumab combination therapy than gastroenterologists with no IBD interest. Moreover, young gastroenterologists who have interest in IBD are more likely to prescribe both infliximab and adalimumab combination therapy than senior gastroenterologists or those with no IBD interest. In addition, gastroenterologists with IBD interest requested more anti-TNF serum drug concentrations and antidrug antibody level tests than those with no IBD interest.
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Affiliation(s)
- Israa Abdullah
- Department of Pharmacy Practice, Faculty of Pharmacy, Kuwait University, Kuwait City, Kuwait
| | - Ghadeer Alhendi
- Department of Pharmacy Practice, Faculty of Pharmacy, Kuwait University, Kuwait City, Kuwait
| | - Anwar Alhadab
- Department of Pharmacy Practice, Faculty of Pharmacy, Kuwait University, Kuwait City, Kuwait
| | - Hajer Alasfour
- Department of Pharmacy Practice, Faculty of Pharmacy, Kuwait University, Kuwait City, Kuwait
| | - Mohammad Shehab
- Division of Gastroenterology, Department of Internal Medicine, Mubarak Alkabeer University Hospital, Kuwait University, Kuwait City, Kuwait
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